注射用培美曲塞二钠与0.9%氯化钠注射液及不同pH的5%葡萄糖注射液的配伍稳定性考察

Stability of Pemetrexed Disodium for Injection in 0.9% Sodium Chloride Injection or 5% Glucose Injection with Different pH

目的:考察注射用培美曲塞二钠与0.9%氯化钠注射液及不同pH的5%葡萄糖注射液在不同温度、光照条件下的配伍稳定性。方法:建立高效液相色谱法测定培美曲塞在不同配伍液中的含量;同时测定不同配伍液的pH、不溶性微粒,并检查外观。结果:培美曲塞二钠与0.9%氯化钠注射液或不同pH的5%葡萄糖注射液配伍后6 h内,配伍液的pH变化<2%,8 h内相对含量变化<2%;而8 h以上,不同放置条件下的配伍液出现pH变化>2%,相对含量变化>2%;所有条件下的不溶性微粒均符合《中国药典》(2010年版)规定。结论:注射用培美曲塞二钠于常温条件配伍后应在6 h内尽快完成临床输注。

OBJECTIVE： To observe the stability of Pemetrexed disodium for injection in 0.9% Sodium chloride injection or 5% Glucose injection with different pH under different temperatures and light conditions. METHODS： HPLC method was estab- lished to determine the contents of pemetrexed disodium in different mixtures; the pH, insoluble particles and appearance of the mixed infusions were detected. RESULTS： Within 6 hours, the variety of pH of pemetrexed disodium in 0.9% Sodium chloride in- jection or 5% Glucose injection with different pH was smaller than 2% ; within 8 hours, the variety of relative contents was also smaller than 2 % ; however, more than 8 hours, the changes mentioned above were larger than 2 % under different conditions. Un- der all conditions, insoluble particles were corresponding with the requirements of Chinese Pharmacopoeia （2010 edition）. CON- CLUSIONS： Pemetrexed disodium for injection should be used up within 6 hours after compatibility under room temperature.